2019 - Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

The current regulatory situation in relation to Medical Devices in the EU.
The purpose of the Medical Device Directives.
Meeting the New Requirements for Conformity Assessment by Product Type.
Understanding the impact the Directive will have on developing and marketing new Medical Device products.
An overview of key areas of the Directive:
Scope of application and definition
Essential Requirements
Medical Device Type & Process Path
Medical Device Technical File
Clinical Investigations
Clinical Evaluations
Notified Bodies
Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.